Release QC testing for DNA and RNA oligonucleotides with identity confirmation, impurity profiling, residual analysis and cGMP-ready documentation.
Bio-Synthesis provides oligonucleotide release QC testing and analytical release testing for DNA and RNA oligos with audit-ready documentation. Panels can cover identity confirmation, purity, impurity profiling, residual analysis, safety testing and general attributes so lots can be reviewed for RUO, GLP, diagnostic or cGMP-oriented workflows.
Choose a standard non-cGMP QC panel for speed, a cGMP/ISO13485 release panel with QA oversight, or a custom package with client method transfer and ICH Q2(R2)-aligned validation.
Final panel design, acceptance criteria and documentation level should be aligned with sequence chemistry, intended use, formulation requirements and regulatory strategy.
A technical snapshot of the core release testing categories Bio-Synthesis can configure for oligonucleotide lots.
A compact view of service pathways, documentation options and turnaround expectations.
Three practical service pathways help match analytical depth, documentation level and turnaround with the intended use of each oligonucleotide batch or release lot.
Methods vary by sequence length, chemistry and modification pattern including PS, PN, boranophosphate, methylphosphonate, 2′-OMe, 2′-F, LNA/BNA, cEt, dyes, lipids, GalNAc and PEG.
Typical specifications are shown as examples only. Final release criteria should be set per program needs, intended use and regulatory strategy.
A structured release workflow keeps the project moving from specification review to documented results, while allowing panel depth to scale for RUO, cGMP, ISO13485 or method-transfer programs.
Share target specifications, oligo modality and intended use. We recommend a tailored QC panel, documentation level and quote.
Chain-of-custody, storage requirements, lot metadata and sample condition are reviewed before testing begins.
Analysts execute approved methods with technical review and QA oversight when required for cGMP or regulated panels.
Methods, chromatograms, spectra, calculations and pass/fail results are compiled against release specifications.
Typically ≥200 µg, method-dependent. Provide extra aliquot for ICP-MS or GC if possible.
Dry or in buffer. Include length, chemistry, purification, concentration and storage conditions.
Ambient for DNA; cold chain suggested for RNA or ASOs. Use insulated packaging and SDS if applicable.
Program fit: Release QC can scale from quick feasibility testing to full cGMP release, stability-indicating methods and long-term analytical support.
Stability
ICH Q1A(R2) stability studies with analytical reporting.
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Methods
Method scouting, transfer and ICH Q2(R2)-aligned validation.
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Manufacturing
RUO to cGMP-aligned oligos with purification and conjugation support.
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Connect release QC with synthesis, purification, stability studies and analytical method support.
Include oligo type, sequence or length, chemistry/modifications, intended use, required tests, target specifications, grade and timeline.
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